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Study Name: Effects of Nutrition and Lung Disease on Growth in Preschoolers with CF
Study Type: Interventional
Intervention Category: Other
Study Sponsor: Powers, Scott

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 2
Recruitment Status: Trial Completed
Study Drug(s): Not Applicable
Number of Participants Being Recruited:
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study is to examine the relationship between a newly developed nutritional method, patient growth, and lung disease. Children with CF have special challenges in obtaining the nutrition needed for proper growth.

Researchers have developed a new method to improve nutrition in preschoolers with CF. The method combines new ideas to encourage children to eat more and develops changes in the presentation of foods that provide better nutrition. Preliminary results show that this new method works to improve energy intake.

In this study researchers will measure lung disease in the preschoolers through images of the lungs obtained using a sensitive technique called high resolution computed tomography, or HRCT. Sixty childrenâ??including some who are using the new nutritional method and some who are notâ??will obtain HRCT scans at the start of the study and then again 18 months later. Using HRCT will help determine whether worsening lung disease slows down growth even when using the new nutritional method. The scans also will also help to determine whether the new nutritional method helps keep the lungs healthy.

The information from these images will also improve our understanding of the development of lung disease in this young group and aid in analyzing results of clinical trials of new therapies for very young children with CF.
ELIGIBILITY
Age: 2 Years - 6 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Powers, Scott
(513) 636-4336
scott.powers@cchmc.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00241969?term=behavior+and+cystic+fibrosis&rank=4
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AZ
  • Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
    Contact Information:
        Molina de Rodriguez, Osmara
        Phone: (520) 891-6767
        Email: omolina@email.arizona.edu
MI
  • University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
OH
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Decker, Beth
        Phone: (513) 803-4325
        Email: Beth.Decker@cchmc.org
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
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